Observational study to evaluate the safety and performance of an anti-bacterial wound dressing
- Conditions
- Health Condition 1: O- Medical and Surgical
- Registration Number
- CTRI/2021/07/034509
- Lead Sponsor
- Essity India Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 112
1.Signed informed consent to participate in this study
2.Men, women or diverse
3.� 18 years of age
4.Patient is mentally and physically able to participate in this study
5.Wound from gastrointestinal or orthopaedical surgeries indicated for treatment with the investigational products for a time period of 14 days
1.Infection of the target wound
2.Patients actively taking antibiotics for other conditions up to the day of surgery (not including surgical prophylaxis or antibiotic use related to the index procedure)
3.Subjects require placement of external fixators
4.Any drug addiction including alcohol
5.Known sensitivity or allergy to any component of the study product
6.Patients who participate in any other clinical study investigating drugs or medical devices
7.Patients not willing to attend at follow-up visits
8.Patients not able to give consent
9.Pregnant or breastfeeding patients
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method